Surgical Management of Irreparable RC Tears

Recruiting

• Conditions: Rotator Cuff Tear

• Registration Number: NCT03878862
• Lead Sponsor: Panam Clinic

Brief Summary

The primary goal will be to compare the early postoperative recovery outcomes and complications from a series of surgical treatments for massive or irreparable rotator cuff tears. The secondary goal will be to assess factors that impact the outcomes of these reconstructions for irreparable posterosuperior rotator cuff tears.

Detailed Description

Prospective, Non-Randomized Cohort Study The surgeons will decide which surgical reconstruction technique should be used to treat patients who have a massive (2+ tendons) or irreparable (Grade 3 or higher fatty infiltration into infraspinatus tendon) rotator cuff tear in the primary or revision setting. Surgical options include arthroscopic superior capsular reconstruction (SCR), arthroscopic assisted latissimus dorsi transfer (aaLDT), or arthroscopic assisted lower trapezius transfer (aaLTT), with arthroscopic biceps tendoesis/tenotomy as a control group.

Each patient will receive an X-ray and MRI to indicate reparable subscapularis tear, teres minor pathology, grade of muscle fatty infiltration, AHI, CSA, Hamada grade, and arthritis grade.

Patients will be assessed pre-operatively and again post-operatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months to collect patient reported outcomes and complications. Assessments will include clinical and shoulder motion evaluations to gauge shoulder range of motion and pathology, as well as questionnaires that evaluate the patients shoulder mobility, ability, pain, and surgical satisfaction. Any adverse events post surgery will also be recorded at the defined assessment time intervals (6 wks, 3m, 6m, 12m, 24,m) and will specifically monitor temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent moderate/severe pain, tendon or graft rupture, and humeral head superior migration.

Graphical comparisons will be made of the patient's recovery for each surgical technique as well as an analysis of patient specific factors based on their demographics forms which could influence the recovery curves.

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Study Start: 2019-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• massive (2+ tendons) or irreparable (see below) rotator cuff tears in the primary or revision setting.

  • Definition of "irreparable": grade 3 or higher fatty infiltration into the infraspinatus

Exclusion criteria:

• Protected populations: prisoners, military, non-English speakers, age <18 years

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analog scale for pain	24-months	10 cm scale with 0 = no pain and 10= extreme pain
Simple shoulder test	24-months	A validated score of items whereby patients indicate ability to perform or not with a lower score equal to worse outcomes. Maximum 12
Veterans Rand - 12	24-months	A validated general health survey with 0 as a poor outcome and 100 as a positive outcome.
American Shoulder and Elbow Score	24-months	Validated shoulder and elbow outcome with a maximum score of 30, with 0 being poor outcome and 30 being the most positive outcome
Western Ontario Rotator Cuff score	24-months	A validated measure with 0 as a poor score and 100 as a positive score.

Trial Locations

Locations (1)

Pan Am Clinic; 🇨🇦 Winnipeg, Manitoba, Canada